CMC Project Manager

Position Summary

The CMC Project Manager coordinates, plans, and executes all Chemistry, Manufacturing & Controls and Quality Assurance activities required for the clinical development of the company’s product(s). This role ensures smooth project execution, efficient communication across teams and partners, and timely delivery of CMC and QA deliverables.

Key Responsibilities

Project Coordination & Planning

• Plan and track all CMC activities across drug substance, drug product, analytics, and supply chain.
• Support the Chief Operating Officer and Chief Medical Officer for the clinical supplies.
• Maintain project timelines, identify potential delays, and propose mitigation actions.
• Organize and facilitate internal and external project meetings, including CDMO/CMO interactions.
• Prepare project dashboards, status reports, and decision‑making materials.

CMC Operations Support

• Assist in coordinating tech transfer, manufacturing campaigns, analytical testing, and stability studies.
• Track documentation, deliverables, and data required for clinical supply readiness.
• Ensure alignment between internal teams and external partners.

Quality Assurance Support

• Manage quality documentation, including SOPs, deviations, CAPAs, and change controls, recall etc.
• Assist in preparing for audits and inspections (internal and external).
• Help ensure that CMC activities comply with GMP and internal quality standards.
• Coordinate QA reviews, approvals of CMC documentation.
• Coordinate internal management review and self-audit.

Regulatory & Documentation Support

• Assist Chief Medical Officer and Chief Scientific Officer in compiling and organizing CMC documentation for regulatory submissions (IND/IMPD updates, briefing packages, etc.).
• Track regulatory commitments and ensure timely delivery of required documents.
• Maintain structured documentation repositories, version control and archiving.

Cross‑Functional Communication

• Act as a central point of coordination between CMC, QA, Regulatory, Clinical, and external partners.
• Ensure clear communication of priorities, deadlines, and risks.
• Support preparation of presentations for governance meetings and external stakeholders.

Qualifications

Education

• Bachelor’s or Master’s degree in chemistry, pharm D. or related field.

Experience

• 3-5 years of experience in the pharmaceutical, CDMO, biotech or small/mid-sized, fast-paced environments.
• At least 2 years of experience in managing CMC activities.
• Good understanding of quality management systems with a strong focus related to GMP.

Skills & Competencies

• Solid understanding of CMC concepts, GMP requirements and clinical trial processes.
• Excellent project management and organizational skills, with ability to manage multiple priorities.
• Strong attention to details.
• Problem-solving mindset with a proactive and pragmatic approach.
• Strong communication skills with the ability to collaborate effectively with CROs, vendors, and investigator sites.
• Computer skills including good knowledge of Microsoft Word, Excel and PowerPoint.
• Fluency in English.